AEGiS-15IAC: Do clinical trials in sub-Saharan Africa comply with established standards of care? A systematic review of HIV, tuberculosis and malaria trials.

15th International AIDS Conference

Bangkok, Thailand - July 11-16, 2004

Do clinical trials in sub-Saharan Africa comply with established standards of care? A systematic review of HIV, tuberculosis and malaria trials.

Int Conf AIDS 2004 Jul 11-16; 15:(abstract no. WeOrC1250)

Kent DM, Mwamburi DM, Bennish ML, Kupelnick B, Ioannides JP
Tufts-New England Medical Center, Boston, United States

BACKGROUND: The minimum standard of care required for subjects in clinical trials conducted in resource-poor settings is a matter of controversy, and international documents offer contradictory guidance.

METHODS: We systematically reviewed all randomized clinical trials (RCTs) conducted in sub-Saharan Africa, published between 1998 and 2003, in 3 clinical domains: HIV disease, tuberculosis (TB) treatment and malaria prophylaxis. Using evidence from the literature and published guidelines, we established criteria for treatment standards that might be considered consistent with best practice for these domains. We then compared the actual care offered in the trial to these standards.

RESULTS: We reviewed 130 eligible articles, describing data from 73 different RCTs. Only 12 (16%) provided care that was not necessarily sub-optimal to both treatment and control patients. Only one of the 34 RCTs that enrolled patients with HIV disease provided adequate anti-retroviral treatment. Conversely, of 13 trials enrolling patients with TB, all provided adequate TB therapy to both treatment and control patients. Among 29 malaria prophylaxis trials, while 21 trials (72%) tested interventions that were not necessarily sub-optimal, only 3 (10%) used any active prophylactic intervention in the control group. Of the 58 trials (81%) that reported on the process of ethical review, all were reviewed by a host (African) institution and 64% were additionally reviewed by an institution in a developed country. Trials reporting ethical review in both African and sponsoring non-African institutions were far more likely to offer sub-optimal care on the specified items than trials reporting ethical review in Af rica only (p<0.0001).

CONCLUSIONS: There was considerable variability in the rates of sub-optimal care between the different conditions examined, suggesting that researchers and ethics committees take into account factors other than the best standard available in rich settings in determining the appropriate level of care for trials in sub-Saharan Africa.

Keywords: AEGIS, Acquired Immunodeficiency Syndrome, Africa South of the Sahara, Tuberculosis, HIV Seropositivity, HIV Infections, Malaria, Randomized Controlled Trials, Research Design, Publishing, Control Groups, Humans, standards, therapy

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